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FDA 510(k)

IVAC DRUG ADMINISTRATION DEVICE

K-Number: K844843 · 1985-04-09

ApplicantY
Decision Date1985-04-09
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IVAC DRUG ADMINISTRATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Y. It received FDA 510(k) clearance on 1985-04-09 under 510(k) number K844843. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IVAC DRUG ADMINISTRATION DEVICE?

IVAC DRUG ADMINISTRATION DEVICE is a medical device that received FDA 510(k) clearance on 1985-04-09. The listed applicant is Y. The 510(k) number is K844843.

When did IVAC DRUG ADMINISTRATION DEVICE receive FDA 510(k) clearance?

IVAC DRUG ADMINISTRATION DEVICE received FDA 510(k) clearance on 1985-04-09, under 510(k) number K844843.

Who is the listed applicant for IVAC DRUG ADMINISTRATION DEVICE?

The FDA 510(k) record lists Y as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IVAC DRUG ADMINISTRATION DEVICE?

The FDA product code for IVAC DRUG ADMINISTRATION DEVICE is FPA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Y as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K955846MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETERK960280IVAC NEEDLE FREE VALVE ADMINISTRATION SETSK953225IVAC BALL VALCE ADMIN. SETSK934095IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETSK940897IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SETK931550EZ ADMINISTRATION SET

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Related Devices (Code: FPA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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